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NCT05811234Completed

A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults

An International, Prospective, Observational Cohort Study to Assess Patient Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (PRO-SCALP)

Source: ClinicalTrials.gov · Last updated 24 Sept 2025

Brief summary (registry, in English)

The main aim of this study is to assess treatment satisfaction, quality of life, treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, sleep quality, and effectiveness, and safety of Calcipotriene/Betamethasone Dipropionate (CAL/BDP) PAD cream in a real-world setting.

Status (registry)
Completed
Study type
Observational
Enrollment
291 (actual)
First submitted
31 Mar 2023
Start date
13 Jun 2023
Primary completion date
1 Oct 2024
Lead sponsor
Almirall, S.A.
Diseases
Psoriasis
NCT number
NCT05811234

What you commit to

  • Study type: Observational
  • Participants enrolled: 291
  • From 13 Jun 2023 to the primary completion date, 1 Oct 2024
  • 37 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants previously treated with systemic drugs for psoriasis (conventional or biologic) within the last 12 weeks prior to inclusion.
  • Concomitant systemic treatment with anti-psoriatic drugs.
  • Concomitant treatment of any type for plaque psoriasis of the scalp.

Other illness

  • Hypersensitivity to the active substances or to any of the excipients of CAL/BDP PAD cream (Wynzora®).
  • Participants with viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, and wounds.

Lab values

  • Participants with known disorders of calcium metabolism.

Other

  • Participants with severe plaque psoriasis, per physician global assessment.
  • Participants with erythrodermic, exfoliative or pustular psoriasis.
  • Pregnant or breastfeeding women, except when the potential benefit justifies the potential risk.
  • Participants unable to comply with the requirements of the study or who in the opinion of the study physician should not participate in the study.
  • Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.

Who the study is looking for

  • Adult (greater than or equal to \[\>=\] 18 years) male or female participants with mild-to-moderate plaque psoriasis of the scalp (defined as scalp-PGA score of 2 or 3 at baseline) with or without involvement of the trunk and limbs, and who may or may not have been previously treated (treatment-naive participants) with other anti-psoriatic therapies.
  • Participants who have been prescribed CAL/BDP PAD cream (Wynzora®) treatment to manage plaque psoriasis of the scalp according to SmPC in routine clinical practice.
  • Willingness and ability to participate in the study; participants must give their written consent to participate.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
DE12
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AhausGermanyUnknown status
DE07
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AugsburgGermanyUnknown status
DE06
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CologneGermanyUnknown status
DE08
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FreisingGermanyUnknown status
DE10
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MainzGermanyUnknown status
DE01
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MannheimGermanyUnknown status
DE05
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MöllnGermanyUnknown status
DE03
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MönchengladbachGermanyUnknown status
DE04
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PforzheimGermanyUnknown status
DE02
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PotsdamGermanyUnknown status
DE11
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RemscheidGermanyUnknown status
ES04
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AlcorcónSpainUnknown status
ES10
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BadalonaSpainUnknown status
ES09
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BarcelonaSpainUnknown status
ES02
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BarcelonaSpainUnknown status
ES06
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BarcelonaSpainUnknown status
ES05
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BilbaoSpainUnknown status
ES03
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GranollersSpainUnknown status
ES07
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LleidaSpainUnknown status
ES08
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PontevedraSpainUnknown status
ES12
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SalamancaSpainUnknown status
ES11
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SevilleSpainUnknown status
ES13
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SevilleSpainUnknown status
ES01
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ZaragozaSpainUnknown status
UK10
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BlackburnUnited KingdomUnknown status
UK02
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ChertseyUnited KingdomUnknown status
UK06
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Chipping NortonUnited KingdomUnknown status
UK08
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CockermouthUnited KingdomUnknown status
UK03
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CreweUnited KingdomUnknown status
UK07
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ExeterUnited KingdomUnknown status
UK14
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GlasgowUnited KingdomUnknown status
UK15
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KirkcaldyUnited KingdomUnknown status
UK11
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LeicesterUnited KingdomUnknown status
UK01
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LondonUnited KingdomUnknown status
UK05
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Saint NeotsUnited KingdomUnknown status
UK04
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SalisburyUnited KingdomUnknown status
UK12
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WellingboroughUnited KingdomUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.